In:
Circulation: Heart Failure, Ovid Technologies (Wolters Kluwer Health), Vol. 7, No. 5 ( 2014-09), p. 752-758
Abstract:
Left ventricle remodeling after anterior wall myocardial infarction leads to increased left ventricle volumes, myocardial stress, and ultimately heart failure (HF). Treatment options are limited for these high-risk HF patients. A study was conducted to assess safety and feasibility of a percutaneous ventricular restoration therapy using the Parachute device in subjects with HF because of a cardiac ischemic event. Methods and Results— Thirty-nine subjects with New York Heart Association class II to IV ischemic HF, ejection fraction between 15% and 40%, and dilated akinetic or dyskinetic anterior-apical wall without the need to be revascularized were enrolled in a prospective, nonrandomized, multicenter investigation testing percutaneous ventricular restoration using the Parachute device. The safety primary end point was defined as successful procedure without device-related major adverse cardiac events during 6 months. Clinical and echocardiographic outcomes were obtained at 6, 12, 24, and 36 months post-treatment. Echocardiographic and end point data were adjudicated independently. Of the 39 subjects enrolled, device implantation was attempted in 34 and successful in 31 patients. Twenty-three subjects reached 3 years post-treatment with the device implanted. New York Heart Association symptom class was improved or maintained in 85% of subjects. Left ventricle end-diastolic volume index and end-systolic volume index were reduced from 128.4±22.1 and 94.9±22.3 mL/m 2 preimplant to 115.2±23.1 and 87.3±18.7 mL/m 2 at 3-year follow-up (end-diastolic volume index, P =0.0056; end-systolic volume index, P =0.4719). The cumulative incidence of HF hospitalization or death was 16.1%, 32.3%, and 38.7% at 12, 24, and 36 months, respectively. By 3-year follow-up, 2 (6.5%) of 31 patients with successful implant had died from cardiac reasons, with no cardiac deaths occurring past 6 months post-treatment. Conclusions— The first series of ischemic HF patients treated with percutaneous ventricular restoration using the Parachute device demonstrates feasibility and safety of the device ≤3 years post-treatment. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifiers: NCT00573560 (US patients) and NCT01286116 (EU patients).
Type of Medium:
Online Resource
ISSN:
1941-3289
,
1941-3297
DOI:
10.1161/CIRCHEARTFAILURE.114.001127
Language:
English
Publisher:
Ovid Technologies (Wolters Kluwer Health)
Publication Date:
2014
detail.hit.zdb_id:
2428100-1
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